Combinational clinical analyzers containing both “wet” and “dry” chemistry platforms in a single apparatus for the testing of biological samples, such as whole blood serum, are now widely used in most modern health care facilities.
So-called “dry” chemistry systems commonly include a sample supply, a number of sample containers, a metering/transport mechanism, and an incubator having a plurality of test read stations as described, for example, in U.S. Pat. No. 3,992,158, the contents of which are hereby incorporated herein by reference in its entirety. A typical protocol starts with the aspiration of a known quantity of a sample into a fluid aspirating/dispensing member. An aliquot of the sample is then dispensed onto a dry slide element which is then loaded into an incubator. After appropriate incubation, the amount or presence of at least one analyte in the sample is determined using, for example, an electrometer, reflectometer or other suitable testing devices.
So-called “wet” chemistry systems on the other hand, use a reaction vessel, such as a cuvette, which receives predetermined volumetric quantities of sample, reagent, and other fluids that are appropriately metered into a reaction vessel in order to perform an assay(s). The “wet” chemistry system commonly includes a metering mechanism to transport a patient sample fluid from a sample supply to the reaction vessel. After a pre-determined incubation period during which one or more reactions occur, a measuring device, such as an optical measuring device is used to pass a beam of light through the reaction vessel and sample. Assays typically used in ‘wet’ chemistry systems include, but are not limited to, spectrophotometric absorbance assays such as end point reaction analysis and rate of reaction analysis, turbidimetric assays, nephelometric assays, radiative energy attenuation assays (such as those described in U.S. Pat. Nos. 4,496,293 and 4,743,561, the contents of which are hereby incorporated herein by reference in their entirety), ion capture assays, color, metric assays, and fluorometric assays, and immunoassays, all of which are well known in the art.
Integration of wet/dry chemistry capabilities into clinical analyzers reduces experimental error, improves work flow and limits the need for human intervention thereby reducing the risk of contamination of lab personnel with human pathogens. One example of a commercially available combination clinical analyzer employing both wet and dry chemistry systems is the Vitros 5,1 FS Chemistry System, which is described in further detail in U.S. Pat. No. 7,250,303 and U.S. Patent Publication No. US 2003/0026733 (each assigned to OrthoClinical Diagnostics, Rochester, N.Y.), the contents of which are incorporated herein by reference in its entirety.
Despite the progress that has been made, these systems still require that patient samples be first processed to remove particulate components before presentation to a clinical analyzer. This processing step remains cumbersome, time consuming and limits the overall efficiency of these analyzers.
Information relevant to attempts to address this problem can be found in U.S. Pat. Nos. D453,573; 4,933,291; 5,384,239; 5,722,553; 5,753,186; 6,001,310; 6,334,842; 6,601,725; 6,622,882; 7,064,823; the published U.S. Publication Numbers US 2001/0019842; US 2005/0204832; US 2005/0208676; US 2007/0003443, US 2007/0017927; International PCT application PCT/AU1992/000236 and European Patent No. EP743095. Each one of these references suffers, however, from one or more of the following disadvantages: the references fail to remedy the inefficient processing of patient samples prior to clinical analysis and also fail to describe a fluid aspirating/dispensing member that permits both sample collection and centrifugation.
For the foregoing reasons, there is an unmet need in the field to improve the efficiency of sample processing prior to analysis by clinical analyzers.